On 24 September 2025, Australia’s Therapeutic Goods Administration (TGA) updated its online list of prescription medicines for evaluation for the months of July, August and September. Among the additions is Celltrion’s July 2025 application for an indication extension to Eydenzelt®, biosimilar to Regeneron’s Eylea® (aflibercept 2mg), for all reference indications.
Eydenzelt® was the first aflibercept biosimilar TGA-approved on 31 March 2025 (solely for myopic CNV). It was followed by Sandoz’s Afqlir® and Enzeevu® on 27 May 2025, and Samsung Bioepis’ Opuviz® on 18 September 2025, which were each approved for all reference indications. Sandoz’s products were the first aflibercept biosimilars to be considered and recommended for listing on Australia’s Pharmaceutical Benefits Scheme with listing anticipated on 1 December 2025.
Aflibercept is currently the subject of patent infringement and revocation proceedings in Australia against Sandoz, with Actor separately challenging Regeneron/Bayer aflibercept patents. On 8 September 2025, the Federal Court of Australia published a judgment refusing to award Regeneron and Bayer an interlocutory injunction against Sandoz to prevent the launch of Sandoz’s Afqlir® in light of Regeneron 2032 expiring MOT patent AU2012205599. Regeneron/Bayer filed an application for leave to appeal that decision on 17 September 2025, with the Full Court to hear the leave application on 29 October 2025. Regeneron/Bayer are also separately seeking preliminary discovery from Sandoz in relation to a second Regeneron aflibercept 2040 expiring process patent AU2020397865, with a hearing scheduled in that matter on 6 November 2025.
Actor Pharmaceuticals, which does not yet have an aflibercept biosimilar approved in Australia filed revocation proceedings in the Australian Federal Court on 5 August 2025 seeking to invalidate Regeneron’s AU2012205599. A first case management hearing in that matter is currently scheduled for 8 October 2025.